[Federal Register Volume 62, Number 230 (Monday, December 1, 1997)]
[Rules and Regulations]
[Pages 63608-63615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31328]
[[Page 63607]]
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Part II
Department of the Interior
_______________________________________________________________________
Fish and Wildlife Service
_______________________________________________________________________
50 CFR Part 20
Migratory Bird Hunting: Revised Test Protocol for Nontoxic Approval
Procedures for Shot and Shot Coating; Final Rule
Federal Register / Vol. 62, No. 230 / Monday, December 1, 1997 /
Rules and Regulations
[[Page 63608]]
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 20
RIN 1018-AB80
Migratory Bird Hunting: Revised Test Protocol for Nontoxic
Approval Procedures for Shot and Shot Coatings
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Final rule.
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SUMMARY: The purpose of this action is to revise the current nontoxic
shot approval procedures by establishing a tiered approval process.
Shot or shot coating approval is considered at each tier. An
environmentally benign shot or a minor modification of previously
approved shot may receive nontoxic approval after the first tier
contingent on existence of appropriate toxicological data and an
ecological risk assessment. If not, further testing would be required.
DATES: This final rule takes effect December 31, 1997.
ADDRESSES: Director (FWS/MBMO), U.S. Fish and Wildlife Service, 634
ARLSQ, 1849 C ST., NW, Washington, D.C. 20240.
FOR FURTHER INFORMATION CONTACT: Paul Schmidt, Chief, or Carol
Anderson, Wildlife Biologist, Office of Migratory Bird Management, 703/
358-1714.
SUPPLEMENTARY INFORMATION: The U.S. Fish and Wildlife Service (Service)
is revising the existing nontoxic shot and shot coating approval
procedures (50 CFR 20.134) by establishing a three-tier approval
process. Shot or shot coating approval is considered at each tier. An
environmentally benign shot or a minor modification of previously
approved shot may receive nontoxic approval after the first tier
contingent upon the existence of appropriate toxicological data and an
ecological risk assessment. The Service has modified the existing
regulation because:
1. From an ecosystem management perspective, in addition to
waterfowl, we need to evaluate species such as invertebrates and fish
as these provide a food base for many waterfowl species;
2. Since the original regulations were in effect, advancements in
the field of ecological risk assessment can be applied to this process;
3. Reduction of time, expense and burden on the Federal Government
and applicants can occur without risk to wildlife; and
4. From an animal welfare standpoint, reduction in numbers of test
animals used can occur without risk to wildlife.
The original procedures were put in place in 1986 and the first
submission requesting approval of nontoxic shot came in October of
1993. Our experience with this shot approval process has shown that the
procedures need modification to accommodate situations where existing
information can minimize the need for full testing. Thus, the Service
and the U.S. Geological Survey--Biological Resources Division
cooperatively have developed an alternative set of procedures for
evaluating nontoxic shot and shot coatings to replace the testing
requirements presently in effect. As with the current procedures, the
new set of approval procedures carry the requirement that the applicant
carry the burden of providing that the candidate shot or shot coating
is nontoxic.
The system has three tiers, with each tier enhancing the
information base on the candidate material. Those candidate materials
where appropriate background information, toxicological data,
ecological risk assessment, and reproductive effects information are
available demonstrating the candidate material to be benign may receive
nontoxic approval. Those candidate materials not approved as a result
of subjecting them to the standards set at Tier 1 will be subject to
the standards of Tier 2, Tier 3, or both.
Tier 1 sets out comprehensive and detailed requirements that must
be provided to the Service in order to consider approval. After
evaluation of Tier 1 information, the Service will determine to grant
or deny approval, or require testing of Tier 2, Tier 3, or both.
The scope of Tier 1 includes: (1) Physical and chemical
characterization of candidate shot or shot coating; (2) information on
the toxicity of the candidate material; (3) an ecological risk
assessment; and (4) effects on reproduction in water birds of the
candidate material.
The scope of Tier 2 includes in vitro erosion rate testing, short-
term (30-day) acute toxicity testing on mallards, and toxicity tests
with invertebrates and early-life stage vertebrates to assess potential
impacts on waterfowl habitat. The inclusion of lead shot (positive) and
steel shot (negative) control groups in the waterfowl feeding studies
is necessary to account for the experimental variability associated
with: (1) Tests performed by different laboratories; (2) a series of
tests performed within a given laboratory; and/or (3) an individual
test, given changing conditions which are beyond control of the
experimental protocol. Further, although the positive control group is
essential to every shot ingestion study series, the Service has
considered the documented history of the results of lead shot ingestion
by waterfowl and reduced the numbers of birds required for that aspect
of the protocol.
The scope of Tier 3 includes chronic exposure under adverse
environmental conditions and effects on reproduction in mallards.
Modification of the experimental procedures to address the specific
composition and erosion characteristics of the candidate shot or shot
coating may be made by the Service, if necessary. If the candidate shot
or shot coating is not metal or metalloid, the Service, with the
applicant, may develop other equivalent testing procedures to evaluate
the effects of the components of the candidate shot and/or shot
coating.
Statistical analyses are to be performed on all data from each
test. For the purpose of this section (20.134) the terms significant
and significantly refer to a (P0.05) finding of
significance.
Other conditions of final approval include residual lead levels and
noninvasive field testing devices. The Service has established a
maximum environmentally acceptable level of lead in shot as trace
amounts of <1 percent="" (august="" 15,="" 1995,="" 61="" fr="" 42492).="" any="" shot="" manufactured="" with="" lead="" levels="" equal="" to="" or="" exceeding="" 1="" percent="" are="" toxic="" and="" therefore,="" illegal.="" further,="" the="" service="" has="" established="" approval="" contingent="" upon="" the="" availability="" of="" a="" noninvasive="" field="" testing="" device="" (august="" 15,="" 1996,="" 61="" fr="" 42492)="" to="" determine="" shot="" material="" in="" the="" shell="" in="" the="" field.="" a="" schematic="" representation="" of="" the="" approval="" process="" follows:="" billing="" code="" 4310-55-p="" [[page="" 63609]]="" [graphic]="" [tiff="" omitted]="" tr01de97.000="" billing="" code="" 4310-55-c="" [[page="" 63610]]="" the="" intent="" of="" the="" shot="" and="" shot="" coating="" approval="" procedure="" is="" to="" ensure="" that,="" in="" addition="" to="" waterfowl,="" other="" natural="" resources="" will="" be="" protected.="" furthermore,="" materials="" that="" toxicologically="" are="" innocuous="" will="" complete="" the="" procedures="" at="" lower="" cost="" and="" with="" less="" paperwork="" for="" both="" the="" service="" and="" the="" applicant.="" in="" summary,="" the="" purpose="" of="" this="" rule="" is="" to="" revise="" the="" current="" shot="" approval="" procedures="" and="" to="" include="" shot="" coatings.="" public="" comment="" and="" responses="" the="" january="" 26,="" 1996,="" proposed="" rule="" published="" in="" the="" federal="" register="" (61="" fr="" 2470)="" invited="" comments="" from="" interested="" parties.="" the="" closing="" date="" for="" receipt="" of="" all="" comments="" was="" may="" 10,="" 1996.="" during="" this="" 115-day="" comment="" period,="" the="" service="" received="" five="" comment="" letters.="" a="" brief="" summary="" of="" those="" comments="" and="" the="" service's="" response="" follows:="" the="" national="" institute="" of="" environmental="" health="" sciences="" limited="" their="" comments="" to="" the="" toxicity="" testing="" (clinical="" observation,="" tissue="" analysis,="" and="" histopathology)="" of="" bismuth="" only,="" and="" as="" such,="" are="" not="" incorporated="" into="" the="" overall="" testing="" protocol.="" the="" missouri="" department="" of="" conservation="" asked="" if="" coatings="" of="" copper,="" nickel,="" and="" zinc="" on="" steel="" shot,="" which="" already="" are="" approved,="" will="" have="" ``grandfathered''="" approval.="" yes,="" they="" will.="" in="" december="" of="" 1986,="" based="" on="" a="" review="" and="" evaluation="" of="" information="" in="" an="" environmental="" assessment,="" the="" director="" issued="" a="" finding="" of="" no="" significant="" impact="" and="" chose="" to="" approve="" the="" use="" of="" copper="" or="" nickel="" coating="" on="" steel="" shot.="" in="" may="" of="" 1993,="" based="" on="" information="" from="" the="" national="" biological="" survey="" (now="" the="" biological="" resources="" division="" of="" the="" u.s.g.s.),="" the="" service,="" and="" manufacturers,="" the="" service="" issued="" an="" approval="" for="" zinc="" chloride="" and/or="" zinc="" chromed="" coating.="" these="" coatings="" will="" retain="" the="" service's="" approval.="" however,="" the="" service="" may="" reconsider="" both="" approvals="" at="" some="" future="" date="" if="" it="" is="" determined="" that="" the="" coatings="" may="" be="" creating="" toxicological="" problems="" for="" migratory="" birds.="" the="" wisconsin="" department="" of="" natural="" resources="" requested="" deletion="" of="" ``the="" requirement="" for="" assessing="" toxicity="" after="" complete="" absorption="" [because]="" we="" suspect="" that="" most="" substances="" that="" would="" pass="" all="" of="" the="" other="" tests="" would="" fail="" this="" test.''="" this="" is="" a="" worst-case="" scenario="" assumed="" in="" the="" risk="" assessment,="" and="" not="" an="" actual="" toxicity="" test="" that="" the="" applicant="" must="" complete.="" to="" ensure="" that="" waterfowl="" will="" be="" protected,="" this="" analysis="" must="" be="" completed.="" the="" national="" wildlife="" federation="" expressed="" concern="" that="" the="" service's="" proposal="" to="" ``scale="" back="" the="" testing="" procedures''="" will="" increase="" the="" potential="" for="" environmental="" harm.="" the="" service's="" decision="" to="" revise="" the="" present="" testing="" protocol="" is="" based="" on="" scientific="" advancements="" in="" risk="" assessment,="" toxicity="" testing,="" and="" modeling.="" in="" actuality,="" the="" new="" test="" protocol="" is="" far="" more="" demanding="" and="" scientifically="" rigorous="" than="" the="" current="" three="" phase="" nontoxic="" shot="" approval="" process="" because="" it="" approaches="" the="" issue="" from="" an="" ecosystem="" management="" perspective="" incorporating="" recent="" advancements="" in="" science.="" the="" new="" test="" protocol="" will="" increase="" protection="" of="" the="" environment="" by="" incorporating="" an="" ecosystem="" approach="" and="" multi-species="" testing="" rather="" than="" just="" a="" single="" species="" test="" with="" mallards.="" the="" nwf="" also="" commented="" that="" ``the="" usfws="" argues="" that="" from="" an="" animal="" welfare="" standpoint,="" the="" numbers="" of="" test="" animals="" used="" can="" be="" reduced.="" in="" fact,="" it="" can="" be="" said="" that="" granting="" approval="" for="" a="" shot="" compound="" which="" has="" not="" been="" throughly="" tested="" makes="" the="" whole="" of="" the="" wild="" waterfowl="" population="" test="" animals.''="" under="" the="" current="" testing="" procedures,="" the="" entire="" ecosystem="" is="" the="" test="" subject="" because="" it="" ignores="" every="" environmental="" and="" biological="" component="" other="" than="" waterfowl.="" the="" service="" is="" striving="" for="" a="" balanced="" ecosystem="" approach="" to="" testing="" without="" being="" overly="" burdensome.="" instead="" of="" using="" large="" numbers="" of="" one="" species,="" the="" service="" is="" incorporating="" the="" test="" with="" several="" different="" species.="" the="" nwf="" also="" stated="" that,="" ``there="" are="" numerous="" cases="" (e.g.,="" the="" pesticide="" ddt)="" in="" which="" the="" harmful="" effects="" of="" a="" product="" became="" apparent="" only="" after="" loss="" of="" reproductive="" viability="" of="" wildlife="" became="" chronic,="" by="" which="" time="" the="" environmentally="" harmful="" substance="" was="" widely="" dispersed="" throughout="" the="" ecosystem.''="" reproductive="" test="" data="" is="" an="" integral="" part="" of="" the="" new="" test="" protocol.="" we="" recognize="" the="" importance="" of="" reproductive="" testing,="" and="" its="" importance="" in="" determining="" the="" safety="" of="" a="" product.="" a="" reproductive="" assessment="" with="" no="" adverse="" or="" inconclusive="" results="" is="" required="" for="" final="" approval="" of="" a="" candidate="" material="" as="" nontoxic.="" ``we="" [nwf]="" remain="" firmly="" opposed="" to="" granting="" full="" or="" final="" approval="" without="" completion="" of="" all="" three="" phases="" of="" testing.="" at="" a="" minimum,="" conditional="" approval="" should="" be="" granted="" only="" after="" the="" currently="" mandated="" phase="" one="" testing="" is="" complete.''="" granting="" of="" final="" approval="" will="" occur="" only="" when="" an="" applicant="" sufficiently="" has="" satisfied="" tier="" 1="" and="" shown="" the="" candidate="" material="" to="" be="" nontoxic.="" if="" tier="" 1="" testing="" results="" are="" inconclusive,="" completion="" of="" tier="" 2,="" tier="" 3,="" or="" both="" will="" be="" required="" showing="" the="" candidate="" material="" to="" be="" nontoxic.="" this="" does="" not="" mean="" that="" completion="" of="" each="" tier="" by="" each="" applicant="" is="" always="" necessary.="" for="" example,="" if="" toxicity="" or="" reproductive="" data="" on="" the="" candidate="" material="" and="" mallards="" already="" exists,="" it="" may="" be="" incorporated="" into="" the="" tier="" 1="" package="" and="" may="" be="" sufficient="" to="" determine="" that="" the="" shot="" and/or="" shot="" coating="" should="" be="" approved.="" safety="" shot="" general="" partner,="" inc.="" reiterates="" their="" original="" concerns="" from="" their="" august="" 27,="" 1991,="" letter="" on="" the="" proposed="" protocol.="" safety="" shot="" states="" that="" ``the="" proposed="" rule="" appears="" to="" address="" our="" concerns="" about="" timing="" issues="" and="" unreasonable="" testing.''="" nepa="" consideration="" in="" compliance="" with="" the="" requirements="" of="" section="" 102(2)(c)="" of="" the="" national="" environmental="" policy="" act="" of="" 1969="" (nepa)="" (42="" u.s.c.="" 4332(c)),="" and="" the="" council="" on="" environmental="" quality's="" regulation="" for="" implementing="" nepa="" (40="" cfr="" 1500-1508),="" the="" service="" prepared="" an="" environmental="" assessment="" (ea)="" in="" november,="" 1996.="" this="" ea="" is="" available="" to="" the="" public="" at="" the="" office="" of="" migratory="" bird="" management,="" u.s.="" fish="" and="" wildlife="" service,="" ms="" 634-arlsq,="" 1849="" c="" street="" nw.,="" washington="" d.c.="" 20240.="" based="" on="" review="" and="" evaluation="" of="" the="" information="" in="" the="" ea,="" the="" service="" determined="" the="" action="" to="" amend="" 50="" cfr="" 20.134="" would="" not="" be="" a="" major="" federal="" action="" that="" significantly="" would="" affect="" the="" quality="" of="" the="" human="" environment.="" endangered="" species="" act="" considerations="" section="" 7="" of="" the="" endangered="" species="" act="" (esa)="" of="" 1972,="" as="" amended="" (16="" u.s.c.="" 1531="" et="" seq.),="" provides="" that,="" ``the="" secretary="" shall="" review="" other="" programs="" administered="" by="" him="" and="" utilize="" such="" programs="" in="" furtherance="" of="" the="" purposes="" of="" this="" act''="" (and)="" shall="" ``insure="" that="" any="" action="" authorized,="" funded="" or="" carried="" out="" *="" *="" *="" is="" not="" likely="" to="" jeopardize="" the="" continued="" existence="" of="" any="" endangered="" species="" or="" threatened="" species="" or="" result="" in="" the="" destruction="" or="" adverse="" modification="" of="" (critical)="" habitat="" *="" *="" *''="" the="" service="" completed="" a="" section="" 7="" consultation="" under="" the="" esa="" for="" this="" rule.="" the="" conclusion="" of="" that="" consultation="" is="" that="" the="" long-term="" effect="" of="" the="" rule="" would="" be="" beneficial,="" and="" that="" the="" rule="" itself="" is="" not="" likely="" to="" adversely="" affect="" listed="" species.="" however,="" as="" the="" nature="" of="" substances="" to="" be="" reviewed="" is="" not="" known="" at="" this="" time,="" each="" application="" will="" be="" reviewed="" for="" potential="" effects="" to="" listed="" species.="" the="" result="" of="" the="" service's="" consultation="" under="" section="" 7="" of="" the="" esa="" is="" available="" to="" the="" public="" through="" the="" office="" of="" migratory="" bird="" management,="" u.s.="" fish="" and="" wildlife="" service,="" ms="" 634="" arlsq,="" 1849="" c="" street="" nw.,="" washington="" d.c.="" 20240.="" [[page="" 63611]]="" regulatory="" flexibility="" act,="" executive="" order="" 12866,="" and="" the="" paperwork="" reduction="" act="" the="" regulatory="" flexibility="" act="" of="" 1980="" (5="" u.s.c.="" 601="" et="" seq.)="" requires="" the="" preparation="" of="" flexibility="" analyses="" for="" rules="" that="" will="" have="" a="" significant="" effect="" on="" a="" substantial="" number="" of="" small="" entities,="" which="" includes="" small="" businesses,="" organizations="" or="" governmental="" jurisdictions.="" since="" this="" is="" a="" revision="" to="" existing="" procedures="" designed="" to="" reduce="" cost="" and="" time="" requirements="" in="" determining="" the="" toxicity="" of="" a="" candidate="" material,="" this="" rule="" will="" have="" no="" significant="" effect="" on="" small="" entities.="" no="" dislocation="" or="" other="" local="" effects,="" with="" regard="" to="" hunters="" and="" others,="" are="" apt="" to="" be="" evidenced.="" the="" information="" collection="" requirements="" contained="" within="" this="" part="" have="" been="" approved="" by="" the="" office="" of="" management="" and="" budget="" (omb)="" under="" 44="" u.s.c.="" 3507="" and="" assigned="" clearance="" number="" 1018-0067="" which="" expires="" on="" 06/30/2000.="" the="" information="" must="" be="" provided="" in="" order="" to="" obtain="" the="" benefit="" of="" being="" approved="" as="" nontoxic="" shot.="" this="" information="" is="" being="" collected="" to="" evaluate="" an="" applicant's="" candidate="" material.="" the="" likely="" respondents="" to="" this="" collection="" of="" information="" will="" be="" companies="" producing="" and/or="" marketing="" shot="" and/or="" shot="" coatings="" who="" wish="" to="" obtain="" approval="" of="" the="" candidate="" shot="" as="" nontoxic="" for="" use="" in="" hunting="" waterfowl="" and="" coots.="" in="" order="" to="" make="" this="" decision,="" the="" service="" requires="" that="" applicants="" submit="" information="" collected="" about="" the="" toxicity="" of="" their="" candidate="" material="" to="" migratory="" birds="" and="" the="" environment.="" this="" data="" provides="" the="" bulk="" of="" the="" application.="" the="" information="" from="" scientific="" literature,="" risk="" assessment="" analysis,="" and="" toxicity="" studies,="" will="" be="" gathered="" and="" packaged="" by="" the="" applicant.="" the="" service="" expects="" to="" receive="" one="" request="" each="" year.="" the="" annual="" burden="" of="" reporting="" and="" record="" keeping="" is="" estimated="" to="" be="" about="" 3,200="" hours.="" the="" principal="" economic="" effect="" of="" this="" rule="" will="" be="" to="" allow="" sport="" hunting="" retailers="" sales="" of="" more="" nontoxic="" shot="" types.="" this="" will="" provide="" some="" additional="" sales,="" however="" these="" sales="" are="" within="" a="" niche="" market="" and="" not="" likely="" to="" dislocate="" any="" other="" products.="" it="" is="" thought="" that="" these="" sales="" may="" slightly="" reduce="" some="" of="" the="" lead="" shot="" sales.="" the="" overall="" effect="" to="" hunting="" expenditures="" in="" general="" will="" be="" minor.="" this="" rule="" will="" accommodate="" situations="" where="" existing="" information="" can="" minimize="" the="" need="" for="" full="" testing="" thereby="" reducing="" the="" time,="" expense,="" and="" burden="" on="" the="" federal="" government="" and="" applicant="" without="" risk="" to="" wildlife.="" therefore,="" this="" rulemaking="" was="" not="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget="" under="" executive="" order="" 12866.="" the="" potential="" applicants="" are="" likely="" to="" be="" small="" entities,="" therefore,="" the="" economic="" effects="" as="" described="" in="" executive="" order="" 12866="" are="" the="" same="" or="" similar="" to="" the="" economic="" impacts="" of="" annual="" hunting="" on="" small="" business="" entities.="" the="" economic="" impacts="" of="" annual="" hunting="" on="" small="" business="" entities="" were="" analyzed="" in="" detail="" and="" a="" small="" entity="" flexibility="" analysis="" (analysis),="" under="" the="" regulatory="" flexibility="" act="" (5="" u.s.c.="" 601="" et="" seq.),="" was="" issued="" by="" the="" service="" in="" 1995="" (copies="" available="" upon="" request="" from="" office="" of="" migratory="" bird="" management).="" the="" analysis="" documented="" the="" significant="" beneficial="" economic="" effect="" on="" a="" substantial="" number="" of="" small="" entities.="" the="" primary="" source="" of="" information="" about="" hunter="" expenditures="" for="" migratory="" game="" bird="" hunting="" is="" the="" national="" hunting="" and="" fishing="" survey,="" which="" is="" conducted="" at="" 5-year="" intervals.="" the="" analysis="" utilized="" the="" 1991="" national="" hunting="" and="" fishing="" survey="" and="" the="" u.s.="" department="" of="" commerce's="" county="" business="" patterns="" from="" which="" it="" was="" estimated="" that="" migratory="" bird="" hunters="" would="" spend="" between="" $10="" and="" $59="" million="" at="" small="" businesses="" in="" 1995.="" the="" approval="" of="" other="" nontoxic="" alternative="" shot="" to="" steel="" will="" have="" a="" minor="" positive="" impact="" on="" small="" businesses="" by="" allowing="" them="" to="" sell="" an="" additional="" nontoxic="" shot="" to="" the="" hunting="" public.="" however,="" the="" overall="" effect="" to="" hunting="" expenditures="" in="" general="" would="" be="" minor.="" unfunded="" mandates="" reform="" the="" service="" has="" determined="" and="" certifies="" pursuant="" to="" the="" unfunded="" mandates="" act,="" 2="" u.s.c.="" 1502="" et="" seq.,="" that="" this="" rulemaking="" will="" not="" impose="" a="" cost="" of="" $100="" million="" or="" more="" in="" any="" given="" year="" on="" local="" or="" state="" government="" or="" private="" entities.="" civil="" justice="" reform--executive="" order="" 12988="" the="" service,="" in="" promulgating="" this="" rule,="" has="" determined="" that="" these="" regulations="" meet="" the="" applicable="" standards="" provided="" in="" sections="" 3(a)="" and="" 3(b)(2)="" of="" executive="" order="" 12988.="" authorship="" the="" primary="" authors="" of="" this="" rule="" are="" cynthia="" m.="" perry="" and="" keith="" a.="" morehouse,="" u.s.="" fish="" and="" wildlife="" service,="" and="" barnett="" rattner,="" biological="" research="" division="" of="" the="" u.s.="" geological="" survey.="" list="" of="" subjects="" in="" 50="" cfr="" part="" 20="" exports,="" hunting,="" imports,="" reporting="" and="" recordkeeping="" requirements,="" transportation,="" wildlife.="" accordingly,="" the="" service="" amends="" part="" 20,="" subchapter="" b,="" chapter="" i="" of="" title="" 50="" of="" the="" code="" of="" federal="" regulations="" as="" follows:="" part="" 20--[amended]="" 1.="" the="" authority="" citation="" for="" part="" 20="" continues="" to="" read="" as="" follows:="" authority:="" 16="" u.s.c.="" 703-712;="" and="" 16="" u.s.c.="" 742="" a-j.="" 2.="" amend="" sec.="" 20.134="" by="" revising="" paragraph="" (b)="" as="" set="" forth="" below="" and="" removing="" paragraph="" (c):="" sec.="" 20.134="" nontoxic="" shot.="" *="" *="" *="" *="" *="" (b)="" application="" and="" review.="" tiered="" strategy="" for="" approval="" of="" nontoxic="" shot="" and="" shot="" coating.="" (1)="" all="" applications="" for="" approval="" under="" this="" section="" must="" be="" submitted="" with="" supporting="" documentation="" to="" the="" director="" in="" accordance="" with="" the="" following="" procedures="" and="" must="" include="" at="" a="" minimum="" the="" supporting="" materials="" and="" information="" covered="" by="" tier="" 1="" in="" the="" tiered="" approval="" system="" as="" follows:="" (2)="" tier="" 1.="" (i)(a)="" applicant="" provides="" statements="" of="" use,="" chemical="" characterization,="" production="" variability,="" volume="" of="" use="" of="" candidate="" material="" and="" shot="" sample="" as="" listed="" in="" paragraphs="" (b)(2)(i)(a)(1)="" through="" (5),="" (b)(2)(i)(b)(1)="" through="" (5),="" and="" (b)(2)(i)(c)(1)="" through="" (3)="" of="" this="" section.="" the="" candidate="" shot="" or="" shot="" coating="" may="" be="" chemically="" analyzed="" by="" the="" service="" or="" an="" independent="" laboratory="" to="" compare="" the="" results="" with="" the="" applicant's="" descriptions="" of="" shot="" composition="" and="" composition="" variability.="" rejection="" of="" the="" application="" will="" occur="" if="" it="" is="" incomplete="" or="" if="" the="" composition="" of="" the="" candidate="" material,="" upon="" analysis,="" varies="" significantly="" from="" that="" described="" by="" the="" applicant.="" (1)="" statement="" of="" proposed="" use,="" i.e.,="" purpose="" and="" types.="" (2)="" description="" of="" the="" chemical="" composition="" of="" the="" intact="" material.="" (i)="" chemical="" names,="" chemical="" abstracts="" service="" numbers="" (if="" available),="" and="" structures.="" (ii)="" chemical="" characterization="" for="" organics="" and="" organometallics="" for="" coating="" and="" core="" [e.g.,="" empirical="" formula,="" melting="" point,="" molecular="" weight,="" solubility,="" specific="" gravity,="" partition="" coefficients,="" hydrolysis="" half-life,="" leaching="" rate="" (in="" water="" and="" soil),="" degradation="" half-life,="" vapor="" pressure,="" stability="" and="" other="" relevant="" characteristics].="" (iii)="" composition="" and="" weight="" of="" shot="" material.="" [[page="" 63612]]="" (iv)="" thickness,="" quantity="" (e.g.,="" mg/shot),="" and="" chemical="" composition="" of="" shot="" coating.="" (3)="" statement="" of="" the="" expected="" variability="" of="" shot="" during="" production.="" (4)="" estimate="" of="" yearly="" volume="" of="" candidate="" shot="" and/or="" coated="" shot="" expected="" for="" use="" in="" hunting="" migratory="" birds="" in="" the="" u.s.="" (5)="" five="" pounds="" of="" the="" candidate="" shot="" and/or="" coated="" shot,="" as="" applicable,="" in="" size="" equivalent="" to="" united="" states="" standard="" size="" no.="" 4="" (0.13="" inches="" in="" diameter).="" (b)="" applicant="" provides="" information="" on="" the="" toxicological="" effects="" of="" the="" shot="" or="" shot="" coating="" as="" follows:="" (1)="" a="" summary="" of="" the="" acute="" and="" chronic="" mammalian="" toxicity="" data="" of="" the="" shot="" or="" shot="" coating="" ranking="" its="" toxicity="" (e.g.,=""><5 mg/kg="super" toxic,="" 5-50="" mg/kg="extremely" toxic,="" 50-500="" mg/kg="very" toxic,="" 500-5,000="" mg/kg="moderately" toxic,="" 5,000-15,000="slightly" toxic,="">15,000 mg/kg = practically nontoxic) with citations.
(2) A summary of known acute, chronic, and reproductive
toxicological data of the chemicals comprising the shot or shot coating
with respect to birds, particularly waterfowl (include LD50 or LC50
data, and sublethal effects) with citations.
(3) A narrative description, with citations to relevant data,
predicting the toxic effect in waterfowl of complete erosion and
absorption of one shot or coated shot in a 24-hour period. Define the
nature of toxic effect (e.g., mortality, impaired reproduction,
substantial weight loss, disorientation and other relevant associated
clinical observations).
(4) A statement, with supporting rationale and citations to
relevant data, that there is or is not any reasonable basis for concern
for shot or coated shot ingestion by fish, amphibians, reptiles or
mammals. If there is some recognized impact on fish, amphibians,
reptiles, or mammals, the Service may require additional study.
(5) Summarize the toxicity data of chemicals comprising the shot or
shot coating to aquatic and terrestrial invertebrates, fish,
amphibians, reptiles, and mammals.
(C) Applicant provides information on the environmental fate and
transport, if any, of the shot or shot coating as follows:
(1) A statement of the alteration of the shot or shot coating,
chemically or physically, upon firing. The statement must describe any
alterations.
(2) An estimate of the environmental half-life of the organic or
organometallic component of the shot or shot coating, and a description
of the chemical form of the breakdown products.
(3) Information on the Estimated Environmental Concentration (EEC)
assuming 69,000 shot per hectare (Bellrose 1959; Pain 1990) for:
(i) A terrestrial ecosystem, assuming complete dissolution of
material in 5 cm of soil. What would be the EEC and would that EEC
exceed existing clean soil standards? (Environmental Protection Agency
[EPA] standards for the Use of Disposal of Sewage Sludge; 40 CFR Part
503). How does the estimated EEC relate to the toxicity threshold for
plants, invertebrates, fish and wildlife?
(ii) An aquatic ecosystem, assuming complete dissolution of the
shot or shot coating in 1 cubic foot of water. What is the estimated
EEC, and how does it compare to the EPA Water Quality Criteria and
toxicity thresholds in plants, invertebrates, fish and wildlife?
(D) Service evaluation of an application.
(1) In reviewing the submission, the Service will use an exceedence
of 1 LD50/square foot as the level of concern (U.S.E.P.A. 1992) as a
criteria in the risk assessment.
(2) In cooperation with the applicant, the Service will conduct a
risk assessment using the Quotient Method (Environmental Protection
Agency 1986): Risk = EEC/Toxicological Level of Concern Compare EEC in
ppm to an effect level (e.g., LD50 in ppm. If Q < 0.1="No" adverse="" effects;="" if="" 0.1=""> Q 10.0 = Possible Adverse
Effects; If Q > 10.0 = Probable Adverse Effects.
(3) Upon receipt of the Tier 1 application, the Director will
review it to determine if the submission is complete. If complete, the
applicant is notified within 30 days of receipt that a thorough review
of the application will commence. A Notice of Application will appear
in the Federal Register announcing the initiation of review of a Tier 1
application. Complete review of a Tier 1 application will occur within
60 days of the date the Notice of Application is published in the
Federal Register.
(E) If, after review of the Tier 1 data, the Service does not
conclude that the shot or shot coating does not impose a significant
danger to migratory birds, other wildlife, and their habitats, the
applicant is advised to proceed with the additional testing described
for Tier 2, Tier 3, or both. A Notice of Review will inform the public
that Tier 1 test results are inconclusive, and Tier 2, Tier 3, or both
testing are required before further consideration.
(F) If review of the Tier 1 data results in a preliminary
determination that the candidate material does not impose a significant
danger to migratory birds, other wildlife, and their habitats, the
Director will publish in the Federal Register a proposed rule stating
the Service's intention to approve this shot or shot coating based on
the toxicological report and toxicity studies. The rulemaking will
include a description of the chemical composition of the candidate shot
or shot coating, and a synopsis of findings under the standards
required for Tier 1. If, at the end of the comment period, the Service
finds no technical or scientific basis upon which to alter its
conclusion, the candidate material will be approved by the publication
of a final rule in the Federal Register. If, after receiving public
comment, the Service determines that all available information does not
establish that the shot and/or shot coating does not impose a
significant danger to migratory birds, other wildlife, and their
habitats, Tier 2, Tier 3, or both testing will be required and a Notice
of Review will appear in the Federal Register. If only one of these two
Tier tests are required, the Service will explain in the notice why the
other is not required. If the applicant chooses not to proceed, the
determination denying approval will appear in the Federal Register.
(ii) Reserved.
(3) Tier 2.
(i) If Tier 2 testing is required, the applicant must submit a plan
that addresses paragraph (b)(3)(ii) requirements. The Director will
review the Tier 2 testing plan submitted by the applicant within 30
days of receipt. The Director may decline to approve the plan, or any
part of it, if deficient in any manner with regard to timing, format or
content. The Director shall apprise the applicant regarding what parts,
if any, of the submitted testing procedures to disregard and any
modifications to incorporate into the Tier 2 testing plan in order to
gain plan approval. All testing procedures will be in compliance with
the Good Laboratory Practices Standards (40 CFR part 160) except where
they conflict with the regulations in this section or with a provision
of an approved plan. The Director, or authorized representative, may
elect to inspect the applicant's laboratory facilities and may decline
to approve the plan and further consideration of the candidate shot if
the facility does not meet the Good Laboratory Practices Standards.
After the plan is accepted, Tier 2 testing will commence. Required
analyses and reports, in accordance with the regulations in this
section, must be sent to the Director. The applicant will ensure that
copies of all the raw data and statistical analyses accompany the
[[Page 63613]]
laboratory reports and final comprehensive report of this test.
(ii) Evaluation of the candidate shot or shot coating will first be
in a standardized test under in vitro conditions (see paragraph
(b)(3)(ii)(A)) that will assess its erosion and any release of
components into a liquid medium in an environment simulating in vivo
conditions of a waterfowl gizzard. Erosion characteristics are to be
compared with those of lead shot and steel shot of comparable size.
Following the erosion rate testing, the applicant must conduct a 30-day
acute toxicity test in mallards, and a test to determine the candidate
shot and/or shot coating effects on selected invertebrates and fish and
include the results in the report for the Director.
(A) In Vitro Erosion Rate Test. Conduct a standardized in vitro
test to determine erosion rate of the candidate shot or shot coating
using the guidelines in Kimball and Munir (1971), unless otherwise
provided by the Service.
(1) Typical test materials:
Atomic absorption spectrophotometer; Drilled aluminum block to
support test tubes; Thermostatically controlled stirring hot plate;
Small Teflon-coated magnets; Hydrochloric acid (pH 2.0) and
pepsin; Capped test tubes; and Lead, steel and candidate shot/coated
shot.
(2) Typical test procedures. Add hydrochloric acid and pepsin to
each capped test tube at a volume and concentration that will erode a
single 4 lead shot at a rate of 5 mg/day. Place three test
tubes, each containing either lead shot, steel shot or candidate shot
and/or coated shot, in an aluminum block on the stirring hot plate. Add
a Teflon coated magnet to each test tube and set the hot
plate at 42 degrees centigrade and 500 revolutions per minute.
Determine the erosion of shot or coated shot daily for 14 consecutive
days by weighing the shot and analyzing the digestion solution with an
atomic absorption spectrophotometer. Replicate the 14-day procedure
five times.
(3) Typical test analyses. Compare erosion rates of the three types
of shot by appropriate analysis of variance and regression procedures.
The statistical analysis will determine whether the rate of erosion of
the shot and/or shot coating is significantly greater or less than that
of lead and steel. This determination is important to any subsequent
toxicity testing.
(B) Acute Toxicity Test--Tier 2 (Short-term, 30-day acute toxicity
test using a commercially available duck food.). Over a 30-day period,
conduct a short-term acute toxicity test that complies with the
guidelines described as follows or as otherwise provided by the
Service:
(1) Typical test materials: 30 male and 30 female hand-reared
mallards approximately 6 to 8 months old (mallards must have plumage
and body conformation that resemble wild mallards); 60 elevated outdoor
pens equipped with feeders and waterers; Laboratory equipped to perform
fluoroscopy, required blood and tissue assays, and necropsies;
Commercial duck maintenance mash; and Lead, steel and candidate shot.
(2) Typical test procedures. House mallards individually in pens
and give ad libitum access to food and water. After 3 weeks, randomly
assign to 3 groups (10 males and 10 females/group), dose with eight
pellets of either No. 4 lead shot (positive control), steel shot
(negative control), or the candidate shot or coated shot. Fluoroscope
birds at 1 week after dosage to check for shot retention. Observe birds
daily for signs of intoxication and mortality over a 30-day period.
Determine body weight at the time of dosing, and at days 15 and 30 of
the test. On days 15 and 30, collect blood by venipuncture, determine
hematocrit, hemoglobin concentration and other specified blood
chemistries. Sacrifice all survivors on day 30. Remove the liver and
other appropriate organs from the sacrificed birds and from birds that
died prior to sacrifice on day 30 for histopathological analysis.
Analyze the organs for lead and compounds contained in the candidate
shot or coated shot. Necropsy all birds to determine any pathological
conditions.
(3) Typical test analyses. Analyze mortality among the specified
groups with appropriate chi-square statistical procedures. Analyze
physiological data and tissue contaminant data by analysis of variance
or other appropriate statistical procedures to include the factors of
shot type and sex. Compare sacrificed birds and birds that died prior
to sacrifice whenever sample sizes are adequate for meaningful
comparison.
(C) Daphnid and Fish Early-Life Toxicity Tests. Determine the
toxicity of the compounds that comprise the shot or shot coating (at
conditions maximizing solubility without adversely affecting controls)
to selected invertebrates and fish. These methods are subject to the
environmental effects test regulations developed under the authority of
the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), as follows:
(1) The first test, the Daphnid Acute Toxicity Test (conducted in
accordance with 40 CFR 797.1300), is a guideline for use in developing
data on the acute toxicity of chemical substances. This guideline
prescribes an acute toxicity test in which Daphnid exposure to a
chemical in static and flow-through systems, with the agencies
assessing the hazard the compound(s) may present to an aquatic
environment.
(2) The second test is the Daphnid Chronic Toxicity Test (conducted
in accordance with 40 CFR 797.1330). This gathers data on the chronic
toxicity of chemical substances in which Daphnids (Daphnia spp.) are
exposed to a chemical in a renewal or flow-through system. The data
from this test are again used to assess the hazard that the compound(s)
may present to an aquatic environment.
(3) A third test, Fish Early Life Stage Toxicity Test (conducted in
accordance with 40 CFR Section 797.1600), assesses the adverse effects
of chemical substances to fish in the early stages of their growth and
development. Data from this test are used to determine the hazard the
compound(s) may present to an aquatic environment.
(iii) After the Tier 2 testing, the applicant will report the
results to the Director. If, after review of the Tier 2 data, the
Service determines that the information does not establish that the
shot or shot coating does not impose a significant danger to migratory
birds, other wildlife, and their habitats, the applicant is advised to
proceed with the additional testing in Tier 3. A Notice of Review
advises the public that, in conjunction with Tier 1 data, Tier 2 test
results are inconclusive and Tier 3 testing is required for continued
consideration.
(iv) If review of the Tier 2 test data results in a preliminary
determination that the candidate shot or shot coating does not impose a
significant danger to migratory birds, other wildlife, and their
habitats, the Director will publish in the Federal Register a proposed
rule stating the Service's intention to approve this shot and/or
coating and why Tier 3 testing is unnecessary. The rulemaking will
include a description of chemical composition of the shot or shot
coating, and a synopsis of findings under the standards required at
Tier 2. If, at the end of the comment period, the Service finds no
technical or scientific basis upon which to deny approval, the
candidate shot or shot coating approval is published as a final rule in
the Federal Register. If, as a result of the comment period, the
Service determines that the information does not establish that the
shot and/or shot coating does not impose a significant danger to
migratory birds, other wildlife, and their habitats, Tier 3 testing
will be required and a Notice of Review published in the
[[Page 63614]]
Federal Register. If the applicant chooses not to proceed, the
determination denying approval of the candidate shot or shot coating
will appear in the Federal Register.
(4) Tier 3.
(i) If the Director determines that the Tier 1 or Tier 2
information is inconclusive, the Director will notify the applicant to
submit a Tier 3 testing plan for conducting further testing as outlined
in paragraphs (b)(4)(i) (A) and (B) of this section. Review, by the
Director, of the Tier 3 testing plan submitted by the applicant will
occur within 30 days of receipt. The Director may decline to approve
the plan, or any part of it, if deficient in any manner with regard to
timing, format or content. The Director shall apprise the applicant
regarding what parts, if any, of the submitted testing procedure to
disregard and any modifications to incorporate into the Tier 3 plan in
order to gain plan approval. All testing procedures should be in
compliance with the Good Laboratory Practices Standards (40 CFR part
160), except where they conflict with the regulations in this section
or with a provision of an approved plan. The Director, or authorized
representative, may elect to inspect the applicant's laboratory
facilities and may decline to approve the plan and further
consideration of the candidate shot and/or shot coating if the facility
is not in compliance with the Good Laboratory Practices Standards.
After acceptance of the plan, Tier 3 testing will commence. Required
analyses and reports must be sent to the Director. The applicant will
ensure that copies of all the raw data and statistical analyses
accompany the laboratory reports and final comprehensive report of this
test.
(A) Chronic Toxicity Test--Tier 3 (Long-term toxicity test under
depressed temperature conditions using a nutritionally-deficient diet).
Conduct a chronic exposure test under adverse conditions that complies
with the general guidelines described as follows unless otherwise
provided by the Service:
(1) Typical test materials: 36 male and 36 female hand-reared
mallards approximately 6 to 8 months old (Mallards must have plumage
and body conformation that resembles wild mallards); 72 elevated
outdoor pens equipped with feeders and waterers; Laboratory equipped to
perform fluoroscopy, required blood and tissue assays, and necropsies;
Whole kernel corn; and Lead, steel, and candidate shot or coated shot.
(2) Typical test procedures.
(i) Conduct this test at a location where the mean monthly low
temperature during December through March is between 20 and 40 degrees
Fahrenheit (-6.6 and 4.4 degrees centigrade, respectively). Assign
individual mallards to elevated outdoor pens during the first week of
December and acclimate to an ad libitum diet of whole kernel corn for 2
weeks. Randomly assign birds to 5 groups (lead group of 4 males and 4
females, 4 other groups of 8 males and 8 females/group). Dose the lead
group (positive control) with one size No. 4 pellet of lead shot. Dose
one group (8 males and 8 females) with eight size No. 4 pellets of
steel shot (negative control) and dose the 3 other groups (8 males and
8 females/group) with one, four and eight size No. 4 pellets of
candidate shot or coated shot.
(ii) Weigh and fluoroscope birds weekly. Weigh all recovered shot
to measure erosion. Determine blood parameters given in the 30-day
acute toxicity test. Provide body weight and blood parameter
measurements on samples drawn at 24 hours after dosage and at the end
of days 30 and 60. At the end of 60 days, sacrifice all survivors.
Remove the liver and other appropriate organs from sacrificed birds and
birds dying prior to sacrifice on day 60 for histopathological
analysis. Analyze organs for lead and other metals potentially
contained in the candidate shot or shot coating. Necropsy all birds
that died prior to sacrifice to determine pathological conditions
associated with death.
(3) Typical test analyses. Analyze mortality among the specified
groups with appropriate chi-square statistical procedures. Any effects
on the previously mentioned physiological parameters caused by the shot
or shot coating must be significantly less than those caused by lead
shot and must not be significantly greater than those caused by steel
shot. Analyze physiological data and tissue contaminant data by
analysis of variance or appropriate statistical procedures to include
the factors of shot type, dose and sex. Compare sacrificed birds and
birds that died prior to sacrifice whenever sample sizes are adequate
for a meaningful comparison.
(B) Chronic Dosage Study--Tier 3 (Moderately long-term study that
includes reproductive assessment). Conduct chronic exposure
reproduction trial with the general guidelines described as follows
unless otherwise provided by the Service:
(1) Typical test materials: 44 male and 44 female hand-reared first
year mallards (Mallards must have plumage and body conformation that
resemble wild mallards); Pens suitable for quarantine and acclimation
and for reasonably holding 5-10 ducks each; 44 elevated, pens equipped
with feeders, waterers and nest boxes; Laboratory equipped to perform
fluoroscopy, required blood and tissue assays, and necropsies; Whole
kernel corn, and commercial duck maintenance and breeder mash; and
Lead, steel and candidate shot or coated shot.
(2) Typical test procedures. (i) Randomly assign mallards to 3
groups (Lead group = 4 males and 4 females; steel group = 20 males and
20 females; candidate shot/coated shot group = 20 males and 20 females)
in December and hold in same-sex groups until mid-January (dates apply
to outdoor test facility only and will reflect where in the U.S. tests
are conducted). Tests conducted in the southern U.S. will need to be
completed in low temperature units. After a 3-week acclimation period
with ducks receiving commercial maintenance mash, provide birds with an
ad libitum diet of corn for 60 days and then pair birds (one pair/pen)
and provide commercial breeder mash. Dosing of the 3 groups with one
pellet of No. 4 lead shot (positive control); eight pellets of No. 4
steel shot (negative control); and eight pellets of No. 4 candidate
shot or coated shot will occur after the acclimation period (day 0) and
redosed after 30, 60, and 90 days. Few, if any, of the lead-dosed birds
(positive control) should survive and reproduce.
(ii) Fluoroscope birds 1 week after dosage to check for shot
retention. Weigh males and females the day of initial dosing (day 0),
at each subsequent dosing, and at death. Measure blood parameters
identified in the 30-Day Acute Toxicity Test in this test using samples
drawn at time of weighing. Note the date of first egg and the mean
number of days per egg laid. Conclude laying after 21 normal, uncracked
eggs are laid or after 150 days. Sacrifice adults after completion of
laying period. Remove the liver and other appropriate organs from
sacrificed birds and from other birds that died prior to sacrifice for
histopathological analysis. Analyze organs and the 11th egg for
compounds contained in the shot or shot coating. Necropsy all birds to
determine any pathological conditions. Check nests daily to collect
eggs. Discard any eggs laid before pairing. Artificially incubate eggs
and calculate the percent shell thickness, percent eggs cracked,
percent fertility (as determined by candling), and percent hatch of
fertile eggs for each female. Provide ducklings with starter mash after
hatching. Sacrifice all ducklings at 14 days of age. Measure survival
to day 14 and weight of the
[[Page 63615]]
ducklings at hatching and sacrifice. Measure blood parameters
identified in the 30-Day Acute Toxicity Test using samples drawn at
sacrificing.
(3) Typical test analyses.
(i) Any mortality, reproductive inhibition or effects on the
physiological parameters in paragraph (b)(4) by the shot or shot
coating must not be significantly greater than those caused by steel
shot. Percentage data is subject to an arcsine, square root
transformation prior to statistical analyses. Physiological and
reproductive data is analyzed by one-tailed t-tests (=0.05),
or other appropriate statistical procedures by the applicant.
(ii) After conclusion of Tier 3 testing, the applicant must report
the results to the Director. If after review of the Tier 3 data
(completion 60 days after receipt of material) the Service determines
that all of the information gathered and submitted in accordance with
Tiers 1, 2, and 3, as applicable, does not establish that the shot or
shot coating does not impose a significant danger to migratory birds,
other wildlife, and their habitats, the applicant will have the option
of repeating the tests that the Director deems are inconclusive. If the
applicant chooses not to repeat the tests, approval of the candidate
shot or shot coating is denied. A Notice of Review will inform the
public that Tier 3 results are inconclusive, the applicant's decision
not to repeat Tier 3 testing, and the Service's subsequent denial of
the shot or shot coating.
(iii) If review of either the initial or repeated Tier 3 test data
results in a preliminary determination that the shot or shot coating
does not impose a significant danger to migratory birds, other wildlife
and their habitats, the Director will publish in the Federal Register a
proposed rule stating the Service's intention to approve this shot or
shot coating and providing the public with the opportunity to comment.
The rulemaking will include a description of the chemical composition
of the shot or shot coating and a synopsis of findings under the
standards required by Tier 3. If at the end of the comment period, the
Service concludes that the shot or shot coating does not impose a
significant danger to migratory birds, other wildlife, or their
habitats, the shot or shot coating will be approved as nontoxic with
publication of a final rule in the Federal Register.
(5) Residual lead levels. The Service's maximum environmentally
acceptable level of lead in shot is trace amounts or <1 percent.="" any="" shot="" manufactured="" with="" lead="" levels="" equal="" to="" or="" exceeding="" 1="" percent="" are="" considered="" toxic="" and,="" therefore,="" illegal.="" (6)="" field="" detection="" device.="" before="" approval="" of="" any="" shot="" for="" use="" in="" migratory="" game="" bird="" hunting,="" a="" noninvasive="" field="" testing="" device="" must="" be="" available="" for="" enforcement="" officers="" to="" determine="" the="" shot="" material="" in="" a="" given="" shell="" in="" the="" field.="" dated:="" november="" 3,="" 1997.="" donald="" j.="" barry,="" acting="" assistant="" secretary="" for="" fish="" and="" wildlife="" and="" parks.="" [fr="" doc.="" 97-31328="" filed="" 11-28-97;="" 8:45="" am]="" billing="" code="" 4310-55-p="">